Northwestern U. Loses Round Over Unauthorized Patient Testing

Northwestern University’s teaching hospital and its chief of cardiac surgery have lost a court bid to dismiss a lawsuit alleging he used unsuspecting patients to test an experimental heart device.

After six years of preliminary maneuvering in the case, a state-court judge ruled last week that key parts of the allegations brought by one patient could move forward.

The cardiac-surgery chief, Patrick M. McCarthy, is accused of leading an experiment in 2006 and 2007 in which about 100 patients received a heart ring — a circular piece of silicone and metal used to fix failing heart valves — without being told it was a test device.

Eventually, more than 600 patients were given a version of the ring before the U.S. Food and Drug Administration ordered Dr. McCarthy to stop the implants and obtain regulatory approval for the device. Dr. McCarthy had described his actions as permissible under FDA rules that allow doctors to make what they consider to be minor modifications of existing FDA-approved devices.

But the FDA concluded the change was more than minor, and evidence in the case has suggested Dr. McCarthy recognized his work as experimental. He gave conference presentations in 2007 and wrote two medical-journal articles in 2008 that emphasized the novelty of his invention.

In preparing such presentations, Dr. McCarthy also asked Northwestern’s institutional review board for permission to view postoperative medical records of patients who had received the experimental devices, without notifying the patients. Records show he made the request in June 2006 and the IRB later approved it. He checked a box on a previous application indicating no medical device was used in the study, and he made no request for IRB review of the actual experimentation. The board approved a similar request the previous year for the undisclosed review of patient records related to another heart ring that Dr. McCarthy was developing.

A Northwestern University spokesman, Alan K. Cubbage, said on Monday he had no comment on the matter.

A Colleague’s Concerns

The investigation that uncovered Dr. McCarthy’s actions has largely been driven by Nalini M. Rajamannan, a former colleague at Northwestern Memorial Hospital, the university’s primary teaching hospital. Dr. Rajamannan was responsible for postoperative care of the patients and said she was surprised to find some were unaware they had been given experimental heart rings.

She brought her concerns to the university, which stood behind Dr. McCarthy. Dr. Rajamannan subsequently was denied tenure and lost her job as an associate professor of medicine at Northwestern after she continued to accumulate evidence suggesting Dr. McCarthy was intentionally experimenting on the patients.

One of those patients, Maureen Obermeier, is the plaintiff in the case involved in last week’s ruling.

Dr. McCarthy’s modified heart-valve device was manufactured by Edwards Lifesciences, a California company that specializes in artificial heart valves. In his ruling last week, Judge William E. Gomolinski of the Circuit Court of Cook County approved the company’s request to be dismissed from the case.

Edwards Lifesciences was dismissed largely because the lack of an experimental designation on the modified ring it made with Dr. McCarthy’s design apparently seemed too tangential to the underlying allegations, said Ms. Obermeier’s lawyer, Ardwin E. Boyer. The judge declined to dismiss complaints of a lack of informed consent and medical battery against the remaining defendants — Dr. McCarthy, the hospital, and the Northwestern Medical Faculty Foundation, which is the faculty-practice plan of the university’s medical school. Trial is expected to begin in March, Mr. Boyer said.

‘These Patients Need to Know’

In an interview on Monday, Dr. Rajamannan said she had persisted in the matter because she fears many of the affected patients may be suffering health problems from the unapproved devices without realizing the underlying cause. “These patients need to know,” she said.

Dean M. Harrison, president and chief executive officer of Northwestern Memorial HealthCare, the teaching hospital’s corporate owner, did send a letter to Ms. Obermeier in January 2009 acknowledging that she had received the heart ring devised by Dr. McCarthy. But Mr. Harrison, in his letter, said he did not consider the device to be experimental, called it “safe and effective,” and emphasized Dr. McCarthy’s status as a “world-renowned cardiothoracic surgeon.” Similar letters were sent to other patients.

In his findings published in 2008 by The Journal of Thoracic and Cardiovascular Surgery, Dr. McCarthy reported no significant problems, including no heart attacks, associated with the 100 implants of his heart-ring invention. But Ms. Obermeier’s lawyer later found medical records of an electrocardiogram from the day of her implant surgery, in November 2006, that showed she suffered an apparent heart attack in the hour after her surgery.

The case also has drawn the attention of Sen. Charles E. Grassley, Republican of Iowa, who has repeatedly written to Northwestern and its leadership seeking details. Mr. Grassley’s investigation helped persuade the FDA to halt the experimentation and require a formal approval process for the device, said the senator’s spokeswoman, Jill Gerber. The senator “found apparent inconsistencies in some statements made by the inventor of the device and Northwestern regarding whether the device was a ‘minor modification’ of pre-existing devices,” she said.

For now, the investigation is on hold, Ms. Gerber said on Monday. “Senator Grassley has done what he can do, given the available information,” she said. “He’s willing to revisit the topic if new information becomes available.”

Paul Basken covers university research and its intersection with government policy. He can be found on Twitter @pbasken, or reached by email at paul.basken@chronicle.com.